CA3003341A1 - Aneurysm occluder - Google Patents
Aneurysm occluder Download PDFInfo
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- CA3003341A1 CA3003341A1 CA3003341A CA3003341A CA3003341A1 CA 3003341 A1 CA3003341 A1 CA 3003341A1 CA 3003341 A CA3003341 A CA 3003341A CA 3003341 A CA3003341 A CA 3003341A CA 3003341 A1 CA3003341 A1 CA 3003341A1
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- Prior art keywords
- occluder
- aneurysm
- frame
- cage
- closed
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- 206010002329 Aneurysm Diseases 0.000 title claims abstract description 55
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- 239000004814 polyurethane Substances 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 3
- 229920002635 polyurethane Polymers 0.000 claims description 3
- 238000001356 surgical procedure Methods 0.000 abstract description 4
- 229910001000 nickel titanium Inorganic materials 0.000 description 15
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 14
- 239000008280 blood Substances 0.000 description 9
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- 208000007536 Thrombosis Diseases 0.000 description 7
- 238000000034 method Methods 0.000 description 7
- 208000001750 Endoleak Diseases 0.000 description 6
- 206010064396 Stent-graft endoleak Diseases 0.000 description 6
- 230000017531 blood circulation Effects 0.000 description 6
- 210000004491 foramen ovale Anatomy 0.000 description 6
- 239000012528 membrane Substances 0.000 description 6
- 208000013914 atrial heart septal defect Diseases 0.000 description 5
- 230000007547 defect Effects 0.000 description 5
- 230000008439 repair process Effects 0.000 description 5
- 239000010935 stainless steel Substances 0.000 description 5
- 229910001220 stainless steel Inorganic materials 0.000 description 5
- 210000004204 blood vessel Anatomy 0.000 description 4
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- 238000003780 insertion Methods 0.000 description 3
- 230000037431 insertion Effects 0.000 description 3
- 229910052760 oxygen Inorganic materials 0.000 description 3
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- 230000002792 vascular Effects 0.000 description 3
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- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 2
- 229910045601 alloy Inorganic materials 0.000 description 2
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- 229920000249 biocompatible polymer Polymers 0.000 description 2
- 230000003073 embolic effect Effects 0.000 description 2
- 230000008175 fetal development Effects 0.000 description 2
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- 210000004971 interatrial septum Anatomy 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
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- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
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- 206010011224 Cough Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 201000008450 Intracranial aneurysm Diseases 0.000 description 1
- 208000008883 Patent Foramen Ovale Diseases 0.000 description 1
- 230000003187 abdominal effect Effects 0.000 description 1
- 210000000709 aorta Anatomy 0.000 description 1
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- 238000010438 heat treatment Methods 0.000 description 1
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- 210000005246 left atrium Anatomy 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12031—Type of occlusion complete occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Neurosurgery (AREA)
- Surgical Instruments (AREA)
Abstract
This invention relates to an aneurysm occluder, and more particularly but not exclusively, to an endovascular aneurysm occluder that can be inserted into an aneurysm cavity by using endovascular surgical procedures. The aneurysm occluder, includes a resiliently deformable cage (2) made of a mesh structure in which the mesh structure is cylindrical in cross section and closed off at opposite ends, where the opposite ends are held and closed off with shanks (4).
Description
=
2 PCT/1B21116/056470 ANEURYSM OCCLUDER
FIELD OF THE INVENTION
This invention relates to an aneurysm occluder, and more particularly but not exclusively, to an endovascular aneurysm occluder that can be inserted into an aneurysm cavity by using endovascular surgical procedures.
BACKGROUND TO THE INVENTION
An aneurysm is an excessive expansion of a wall segment of an artery and occurs when a wall segment of an artery weakens. Blood pressure in the artery creates the swelling at the weakened wall section. The swelling is commonly referred to as an aneurysm cavity or aneurysm sac. As the size of the aneurysm increases, the risk of rupture increases. A rupture can cause internal bleeding which may result in severe complications and even death.
Endovascular Aneurysm Repair or Endovascular Aortic Repair ("EVAR") is a widely accepted corrective surgical procedure to repair an aneurysm of the aorta (abdominal or thoracic). The procedure involves insertion of a vascular prosthesis, commonly referred to as a stent graft or graft device. The graft device is tubular and provides an artificial lumen for blood to flow, replacing, or locating inside, the damaged artery, thereby immediately taking pressure off of the damaged portion of the blood vessel.
The procedure is performed percutaneously by, for example, making two small incisions in the groin to expose the femoral arteries and feeding a synthetic stent graft through these arteries, with catheters and guide-wires, until the stent graft is positioned. The damaged and expanded part of the blood vessel is internally lined by the stent graft and the stent graft attaches, by radial force at either end to the normal, healthy portions of proximal and distal arteries.
The vascular prosthesis must be attached to the blood vessel in such a way that there is a strong, tight seal around the normal, healthy proximal and distal artery so that blood will not escape into the aneurysm sac. In practice, it is often difficult to attach the stent graft to the ends of the blood vessel in such a way that there is a permanent strong, tight seal between the proximal and distal artery and opposing ends of the stent graft and, as a result, blood flow into the aneurysm sac ("endoleak") may occur. An endoleak may occur in up to 20% of all cases and is considered to be a failure of treatment and may be life-threatening.
Endoleak can be treated in a variety of ways. One way to treat endoleak is by open surgical repair and complete replacement of the stent graft. Open surgical repair and the insertion of a new graft carry a high operative mortality rate. Inducing thrombosis in the aneurysm sac is often a successful alternative way of treating the endoleak.
Thrombosis can be induced by injecting a liquid embolic agent, containing a biocompatible polymer, into the endoleak sac. Thrombosis can also be induced in aneurysms by a procedure called endovascular coiling. Endovascular coiling involves packing platinum coils into the aneurysm sac, through a catheter, to restrict blood circulation thereby inducing thrombosis.
= CA 03003341 2018-04-26 =
A disadvantage of injecting a liquid embolic agent into the aneurysm sac is that the biocompatible polymer dissolves over time and is absorbed into the blood stream. A
disadvantage of endovascular coiling is that aneurysms are often incompletely treated and carry a risk of aneurysm recurrence. In addition, coils are smaller in size to the aneurysm sac and may not fill the aneurysm sac completely.
United states patent application number US 2011/0054519 Al in the name of Matte Neuss entitled "Device for closing defects in the vascular system" discloses a self-expanding device, particularly an implant, for closing defect openings in the human or animal body, which device, in a first state, has the shape of an elongated tube with slotted segments and in a second state has a shortened shape with formation of at least one open or substantially closed hollow structure of considerable transverse extent, where in the slotted segments of the tube form individual webs that are each connected to adjacent webs such that a net-like overall structure is obtained in the second state. The device described in this patent is for treating (closing) Atrial Septal Defects (ASD) or patent foramen ovate (PFO). ASD is a form of a congenital heart defect in which blood flows between the normally separated two upper chambers, the atria of the heart. The atria are separated by a dividing wall, the inter-atrial septum. If this septum is defective or absent, then oxygen-rich blood can flow directly from the left side of the heart to mix with the oxygen-poor blood in the right side of the heart, or vice versa. This can lead to lower-than-normal oxygen levels in the arterial blood that supplies the brain, organs, and tissues. An ASD may not produce noticeable signs or symptoms, especially if the defect is small. An ASD may be caused when the foramen ovale does not close properly after birth. During development of the fetus, the interatrial septum develops to separate the left and right atria. However, a hole in the
FIELD OF THE INVENTION
This invention relates to an aneurysm occluder, and more particularly but not exclusively, to an endovascular aneurysm occluder that can be inserted into an aneurysm cavity by using endovascular surgical procedures.
BACKGROUND TO THE INVENTION
An aneurysm is an excessive expansion of a wall segment of an artery and occurs when a wall segment of an artery weakens. Blood pressure in the artery creates the swelling at the weakened wall section. The swelling is commonly referred to as an aneurysm cavity or aneurysm sac. As the size of the aneurysm increases, the risk of rupture increases. A rupture can cause internal bleeding which may result in severe complications and even death.
Endovascular Aneurysm Repair or Endovascular Aortic Repair ("EVAR") is a widely accepted corrective surgical procedure to repair an aneurysm of the aorta (abdominal or thoracic). The procedure involves insertion of a vascular prosthesis, commonly referred to as a stent graft or graft device. The graft device is tubular and provides an artificial lumen for blood to flow, replacing, or locating inside, the damaged artery, thereby immediately taking pressure off of the damaged portion of the blood vessel.
The procedure is performed percutaneously by, for example, making two small incisions in the groin to expose the femoral arteries and feeding a synthetic stent graft through these arteries, with catheters and guide-wires, until the stent graft is positioned. The damaged and expanded part of the blood vessel is internally lined by the stent graft and the stent graft attaches, by radial force at either end to the normal, healthy portions of proximal and distal arteries.
The vascular prosthesis must be attached to the blood vessel in such a way that there is a strong, tight seal around the normal, healthy proximal and distal artery so that blood will not escape into the aneurysm sac. In practice, it is often difficult to attach the stent graft to the ends of the blood vessel in such a way that there is a permanent strong, tight seal between the proximal and distal artery and opposing ends of the stent graft and, as a result, blood flow into the aneurysm sac ("endoleak") may occur. An endoleak may occur in up to 20% of all cases and is considered to be a failure of treatment and may be life-threatening.
Endoleak can be treated in a variety of ways. One way to treat endoleak is by open surgical repair and complete replacement of the stent graft. Open surgical repair and the insertion of a new graft carry a high operative mortality rate. Inducing thrombosis in the aneurysm sac is often a successful alternative way of treating the endoleak.
Thrombosis can be induced by injecting a liquid embolic agent, containing a biocompatible polymer, into the endoleak sac. Thrombosis can also be induced in aneurysms by a procedure called endovascular coiling. Endovascular coiling involves packing platinum coils into the aneurysm sac, through a catheter, to restrict blood circulation thereby inducing thrombosis.
= CA 03003341 2018-04-26 =
A disadvantage of injecting a liquid embolic agent into the aneurysm sac is that the biocompatible polymer dissolves over time and is absorbed into the blood stream. A
disadvantage of endovascular coiling is that aneurysms are often incompletely treated and carry a risk of aneurysm recurrence. In addition, coils are smaller in size to the aneurysm sac and may not fill the aneurysm sac completely.
United states patent application number US 2011/0054519 Al in the name of Matte Neuss entitled "Device for closing defects in the vascular system" discloses a self-expanding device, particularly an implant, for closing defect openings in the human or animal body, which device, in a first state, has the shape of an elongated tube with slotted segments and in a second state has a shortened shape with formation of at least one open or substantially closed hollow structure of considerable transverse extent, where in the slotted segments of the tube form individual webs that are each connected to adjacent webs such that a net-like overall structure is obtained in the second state. The device described in this patent is for treating (closing) Atrial Septal Defects (ASD) or patent foramen ovate (PFO). ASD is a form of a congenital heart defect in which blood flows between the normally separated two upper chambers, the atria of the heart. The atria are separated by a dividing wall, the inter-atrial septum. If this septum is defective or absent, then oxygen-rich blood can flow directly from the left side of the heart to mix with the oxygen-poor blood in the right side of the heart, or vice versa. This can lead to lower-than-normal oxygen levels in the arterial blood that supplies the brain, organs, and tissues. An ASD may not produce noticeable signs or symptoms, especially if the defect is small. An ASD may be caused when the foramen ovale does not close properly after birth. During development of the fetus, the interatrial septum develops to separate the left and right atria. However, a hole in the
3 WO 2017/072692 PCT/1B2016/(156470 septum called the foramen ovale, allows blood from the right atrium to enter the left atrium during fetal development. This opening allows blood to bypass the nonfunctional fetal lungs while the fetus obtains its oxygen from the placenta. A layer of tissue called the septum prim urn acts as a valve over the foramen ovale during fetal development. After birth, the pressure in the right side of the heart drops as the lungs open and begin working, causing the foramen ovale to close entirely. In approximately 25% of adults, the foramen ovale does not entirely seal. In these cases, any elevation of the pressure in the pulmonary circulatory system (due to pulmonary hypertension, temporarily while coughing, etc.) can cause the foramen ovale to remain open.
This is known as a patent foramen ovale (PFO), which is a type of atrial septa!
defect.
Furthermore, the devices described herein are relatively small and are meant to fill a small defect or "hole" by constricting itself into the "hole" like a meshed plug. It does not include internal large shelves or plates that are spaced apart by 2 to 3 cm thereby providing multiple barriers to blood flow. Once these devices are in their deployed state it is a constricting mesh that provides resistance to bloom flow rather than a large set of multiple deformable plates. In its deployed state the device restricts blood flow by Constricting and tightening an external mesh rather than an expanded system of multiple internally placed plates. The devices described in this patent application are used to close a hole in a membrane and not to enhance thrombosis in an aneurysm sac. The device are not intended for and are not suitable for placement in an aneurysm sac.
United States patent application number US 2011/0152993 Al in the name of Sequent Medical Inc., entitled "Multiple layer filamentary devices or treatment of vascular defects" discloses devices and methods for treatment of a patient's vasculature with
This is known as a patent foramen ovale (PFO), which is a type of atrial septa!
defect.
Furthermore, the devices described herein are relatively small and are meant to fill a small defect or "hole" by constricting itself into the "hole" like a meshed plug. It does not include internal large shelves or plates that are spaced apart by 2 to 3 cm thereby providing multiple barriers to blood flow. Once these devices are in their deployed state it is a constricting mesh that provides resistance to bloom flow rather than a large set of multiple deformable plates. In its deployed state the device restricts blood flow by Constricting and tightening an external mesh rather than an expanded system of multiple internally placed plates. The devices described in this patent application are used to close a hole in a membrane and not to enhance thrombosis in an aneurysm sac. The device are not intended for and are not suitable for placement in an aneurysm sac.
United States patent application number US 2011/0152993 Al in the name of Sequent Medical Inc., entitled "Multiple layer filamentary devices or treatment of vascular defects" discloses devices and methods for treatment of a patient's vasculature with
4 some embodiments configured for delivery with a micro-catheter for treatment of the cerebral vasculature of a patient. Some embodiments may include a permeable shell and inner structure configured to occlude blood flow there-through. The devices disclosed in this patent application are directed to blocking a flow of fluid through a tubular vessel or into a small interior chamber of a saccular cavity or vascular defect within a mammalian body. More specifically, the embodiments disclosed are directed to devices and methods for treating a vascular defect of a patient including some embodiments directed specifically to the treatment of cerebral aneurysms of patients.
As is the case with the devices referred to in the previous patent discussed above, there are no additional or different material thrombotic enhancement devices or agents inside the devices described in this patent application.
International patent application publication number WO 2013/005195 Al published under international application number PCT/182012/053483 entitled "Aneurysm occluder" discloses an endovascular aneurysm occluder that can be inserted into an aneurysm cavity by using endovascular surgical procedures. The occluder enhances thrombosis of an aneurysm cavity and includes a housing consisting of a plurality of strands woven to form a mesh; a 1st securing means located at an end of the housing for gathering and securing the strands together; and a plurality of this shaped inserts located within the housing and secure to the housing. The disc shaped inserts enhances the occlusion of the aneurysm cavity.
As is the case with the devices referred to in the previous patent discussed above, there are no additional or different material thrombotic enhancement devices or agents inside the devices described in this patent application.
International patent application publication number WO 2013/005195 Al published under international application number PCT/182012/053483 entitled "Aneurysm occluder" discloses an endovascular aneurysm occluder that can be inserted into an aneurysm cavity by using endovascular surgical procedures. The occluder enhances thrombosis of an aneurysm cavity and includes a housing consisting of a plurality of strands woven to form a mesh; a 1st securing means located at an end of the housing for gathering and securing the strands together; and a plurality of this shaped inserts located within the housing and secure to the housing. The disc shaped inserts enhances the occlusion of the aneurysm cavity.
5 OBJECT OF THE INVENTION
It is an object of this invention to provide an aneurysm occluder which, at least partially, alleviates some of the abovementioned difficulties.
SUMMARY OF THE INVENTION
In accordance with this invention there is provided an aneurysm occluder, comprising of a resiliently deformable cage made of a mesh structure in which the mesh structure is cylindrical in cross section and closed off at opposite ends, where the opposite ends are held and closed off with shanks.
There is further provided for the mesh strands to be double strands.
A still further feature of the invention provides for the cage to have a frame insert.
A further feature provides for the frame insert to be a substantially rectangular frame, having sheet material attached therein, with the frame bent to form a number of distinct sections.
The frame is resiliently deformable from its bent condition so that it forms the distinct sections. This is achieved through a manufacturing process, as is known in the art.
The cage further includes sheet inserts at its opposite ends.
It is an object of this invention to provide an aneurysm occluder which, at least partially, alleviates some of the abovementioned difficulties.
SUMMARY OF THE INVENTION
In accordance with this invention there is provided an aneurysm occluder, comprising of a resiliently deformable cage made of a mesh structure in which the mesh structure is cylindrical in cross section and closed off at opposite ends, where the opposite ends are held and closed off with shanks.
There is further provided for the mesh strands to be double strands.
A still further feature of the invention provides for the cage to have a frame insert.
A further feature provides for the frame insert to be a substantially rectangular frame, having sheet material attached therein, with the frame bent to form a number of distinct sections.
The frame is resiliently deformable from its bent condition so that it forms the distinct sections. This is achieved through a manufacturing process, as is known in the art.
The cage further includes sheet inserts at its opposite ends.
6 = CA 03003341 2018-04-26 These sheets are made of any flat sheet material made from, preferably, polyurethane or ptfe. In this specification the sheets are also referred to as plates.
Each shank terminates at its outer end in a bulbous gripping member.
The bulbous gripping members facilitate the grasping by clawed forceps during delivery.
This invention extends to a method of manufacturing an aneurism occluder comprising the steps of providing the closed off double strand mesh cage with shanks and inserting a formable frame insert therein.
These and other features of the invention are described in more detail below.
BRIEF DESCRIPTION OF DRAWINGS
One embodiment of the invention is described below, by way of example only, and with reference to the accompanying drawings in which:
Figure 1: is a perspective view of a first embodiment of an aneurysm occluder in accordance with the present invention;
Figure 2: is a side view of the aneurysm occluder of figure 1;
Figure 3: is an end view of the aneurysm occluder of figures 1 and 2;
Each shank terminates at its outer end in a bulbous gripping member.
The bulbous gripping members facilitate the grasping by clawed forceps during delivery.
This invention extends to a method of manufacturing an aneurism occluder comprising the steps of providing the closed off double strand mesh cage with shanks and inserting a formable frame insert therein.
These and other features of the invention are described in more detail below.
BRIEF DESCRIPTION OF DRAWINGS
One embodiment of the invention is described below, by way of example only, and with reference to the accompanying drawings in which:
Figure 1: is a perspective view of a first embodiment of an aneurysm occluder in accordance with the present invention;
Figure 2: is a side view of the aneurysm occluder of figure 1;
Figure 3: is an end view of the aneurysm occluder of figures 1 and 2;
7 Figure 4: is a side view of a first embodiment of an insert of the aneurysm occluder of figures 1 to 3;
Figure 5: shows a plan view of the insert of figure 4 before it is shaped and placed inside housing of the aneurysm occluder;
Figure 6: shows a second embodiment of an insert of the aneurysm occluder of figures 1 to 3;
Figure 7: shows a first step in a method of inserting the insert into the housing of the aneurysm occluder;
Figure 8: shows a second step in a method of inserting the insert into the housing of the aneurysm occlude; and Figure 9: shows a second embodiment of the occluder.
DETAILED DESCRIPTION OF THE DRAWINGS
With reference to the drawings, an aneurysm occluder is generally indicated by reference numeral 1.
The aneurysm occluder 1 has a deformable housing or cage 2 which consists of a plurality of metallic strands woven to form a mesh. The strands may be stainless steel
Figure 5: shows a plan view of the insert of figure 4 before it is shaped and placed inside housing of the aneurysm occluder;
Figure 6: shows a second embodiment of an insert of the aneurysm occluder of figures 1 to 3;
Figure 7: shows a first step in a method of inserting the insert into the housing of the aneurysm occluder;
Figure 8: shows a second step in a method of inserting the insert into the housing of the aneurysm occlude; and Figure 9: shows a second embodiment of the occluder.
DETAILED DESCRIPTION OF THE DRAWINGS
With reference to the drawings, an aneurysm occluder is generally indicated by reference numeral 1.
The aneurysm occluder 1 has a deformable housing or cage 2 which consists of a plurality of metallic strands woven to form a mesh. The strands may be stainless steel
8 of nickel titanium (Nitinol). The mesh is tubular and has closed off ends to be generally sausage shaped in a relaxed position. The strands of the mesh are secured in stainless steel shanks (or securing means) at oppose ends of the cage. The shanks act as dot markers on an X-ray display to assist with insertion of the occluder during an operation.
The occluder 1 further has first securing means 3 which is located at a first end of the housing 2. The securing means, secures at its outer end 3, to an applicator's operational end, which would be an end of a guide wire in a catheter tube 11.
A screw threaded end of the guide wire screws into a blind bore 4 in the securing means. The blind bore 4 is co-axial with the main axis of the housing 2.
An insert 3 is located within the housing 2. The insert is not secured to the housing as its resilient frame holds it in place when it expands, as is described below.
The housing is biased to its relaxed tubular shape and may be compressed to take the shape of an inside of a catheter tube 11 or aneurysm sac 12 in which it is placed.
The insert 3, is made of a thin polytetraflouroethylene sheet or membrane 5.
At its periphery, the membrane 5 is attached to a frame 6. The frame 6 is a closed loop wire made of nitinol. It will be appreciated by those skilled in the art that other suitable material may be used for the membrane such as polyurethane.
Nickel Titanium (NiTi) is a shape memory alloy also commonly referred to by its trade name, Nitinol. Above its transformation temperature, Nitinol is superelastic, able to withstand a large amount of deformation when a load is applied and return to its
The occluder 1 further has first securing means 3 which is located at a first end of the housing 2. The securing means, secures at its outer end 3, to an applicator's operational end, which would be an end of a guide wire in a catheter tube 11.
A screw threaded end of the guide wire screws into a blind bore 4 in the securing means. The blind bore 4 is co-axial with the main axis of the housing 2.
An insert 3 is located within the housing 2. The insert is not secured to the housing as its resilient frame holds it in place when it expands, as is described below.
The housing is biased to its relaxed tubular shape and may be compressed to take the shape of an inside of a catheter tube 11 or aneurysm sac 12 in which it is placed.
The insert 3, is made of a thin polytetraflouroethylene sheet or membrane 5.
At its periphery, the membrane 5 is attached to a frame 6. The frame 6 is a closed loop wire made of nitinol. It will be appreciated by those skilled in the art that other suitable material may be used for the membrane such as polyurethane.
Nickel Titanium (NiTi) is a shape memory alloy also commonly referred to by its trade name, Nitinol. Above its transformation temperature, Nitinol is superelastic, able to withstand a large amount of deformation when a load is applied and return to its
9 = CA 03003341 2018-04-26 original shape when the load is removed. Below its transformation temperature, it displays the shape memory effect. When it is deformed it will remain in that shape until heated above its transformation temperature, at which time it will return to its original shape.
Nitinol is typically composed of approximately 55% Nickel by weight. Making small changes in the composition, can change the transition temperature of the alloy significantly. For this reason, Nitinol may or may not be superelastic at room temperature. These unique properties and tailorability of Nitinol to be used in a wide range of temperatures makes it suitable for many applications, particularly in medicine.
Nitinol is a shape memory alloy (SMA, also known as a smart alloy or memory metal or muscle wire) that "remembers" its geometry. After a sample of SMA has been deformed from its original crystallographic configuration, it regains its original geometry by itself during heating (one-way effect) or, at higher ambient temperatures, simply during unloading (pseudo-elasticity or superelasticity). These extraordinary properties are due to a temperature-dependent martensitic phase transformation from a low-symmetry to a highly symmetric crystallographic structure.
The membrane may be glued or sutured to the frame. In a preferred embodiment, the membrane is glued to the frame with "its own" PU.
In use, the occluder 1 is attached to the end of a guide wire, deformed and placed in a catheter tube. The deformation causes the housing and frame to collapse. The occluder 1 is then placed in the aneurysm cavity using the catheter as is known in the art. The occluder is allowed to expand and fill the cavity taking up the shape of the cavity. The mesh housing 2 takes the shape of the cavity insofar as it fits inside the cavity and the insert expands inside the housing.
Two occluders are inserted in an aneurysm sac.
The material used is nitinol 0.1 mm woven as a double strand to create a mesh.
The double strand increases radial expansion so that the deployed device opens up within the aneurysm sac. Hence 48 X2 sets of wires can be used to construct a device that is 8 cm long. The wires are woven into a smooth shoulder distally to fit into the neck of the aneurysm sac. The round cylinder shape was created to fit into the aneurysm sac as well as to mould around the stent graft. The proximal and distal ends of the device (nitinol wires) are captured by a stainless steel shank. This aids visualization of the device on x-ray, when inserted. The stainless steel ends are more visible than the nitinol strands and appear as 2 "dot markers" on x-ray.
The plates have a nitinol frame and are joined together (as shown). The plates may be ptfe or p.u: The frame ensures expansion of the plates when deployed. The plates and frames are connected to each other to maintain position within the nitinol cage as well as to aid pushability of the device as it passes along the sheath during deployment. The plates and frame are made as a separate unit from the nitinol cage.
It may be attached to the cage at either end. This again allows for stability of the plate position after deployment as well as aids pushability during deployment.
= CA 03003341 2018-04-26 The proximal and distal surfaces of the cage may be covered by additional layers of thin p.u.. These layers may be inserted, and may be attached, on an inside surface of the opposite proximal and distal ends of the cage. Hence a total of 5 p.u.
plates aid thrombogenicity: 2 at either end of the cage and 3 internally lined as a separate framed piece.
The stainless steel shanks may be modified to be grasped by clawed-forceps during delivery as is shown in figure 9. The shanks terminate in bulbous grasping heads. In an alternative embodiment, the shoulders of the occulder may be more rounded as shown.
This invention thus provides an aneurysm occluder which can fill or assist to fill the cavity of an aneurysm. It will be readily appreciated by persons skilled in the art that when the aneurysm occluder 1 is constrained in the aneurysm cavity, the housing and insert slows or inhibits flow of blood and thus promotes thrombosis.
It will be appreciated that many variations are possible with the present embodiment according to the invention without departing from the scope of spirit of the invention.
BREDENKAMP ATTORNEYS
AGENTS/ATTORNEYS FOR THE APPLICANT
Nitinol is typically composed of approximately 55% Nickel by weight. Making small changes in the composition, can change the transition temperature of the alloy significantly. For this reason, Nitinol may or may not be superelastic at room temperature. These unique properties and tailorability of Nitinol to be used in a wide range of temperatures makes it suitable for many applications, particularly in medicine.
Nitinol is a shape memory alloy (SMA, also known as a smart alloy or memory metal or muscle wire) that "remembers" its geometry. After a sample of SMA has been deformed from its original crystallographic configuration, it regains its original geometry by itself during heating (one-way effect) or, at higher ambient temperatures, simply during unloading (pseudo-elasticity or superelasticity). These extraordinary properties are due to a temperature-dependent martensitic phase transformation from a low-symmetry to a highly symmetric crystallographic structure.
The membrane may be glued or sutured to the frame. In a preferred embodiment, the membrane is glued to the frame with "its own" PU.
In use, the occluder 1 is attached to the end of a guide wire, deformed and placed in a catheter tube. The deformation causes the housing and frame to collapse. The occluder 1 is then placed in the aneurysm cavity using the catheter as is known in the art. The occluder is allowed to expand and fill the cavity taking up the shape of the cavity. The mesh housing 2 takes the shape of the cavity insofar as it fits inside the cavity and the insert expands inside the housing.
Two occluders are inserted in an aneurysm sac.
The material used is nitinol 0.1 mm woven as a double strand to create a mesh.
The double strand increases radial expansion so that the deployed device opens up within the aneurysm sac. Hence 48 X2 sets of wires can be used to construct a device that is 8 cm long. The wires are woven into a smooth shoulder distally to fit into the neck of the aneurysm sac. The round cylinder shape was created to fit into the aneurysm sac as well as to mould around the stent graft. The proximal and distal ends of the device (nitinol wires) are captured by a stainless steel shank. This aids visualization of the device on x-ray, when inserted. The stainless steel ends are more visible than the nitinol strands and appear as 2 "dot markers" on x-ray.
The plates have a nitinol frame and are joined together (as shown). The plates may be ptfe or p.u: The frame ensures expansion of the plates when deployed. The plates and frames are connected to each other to maintain position within the nitinol cage as well as to aid pushability of the device as it passes along the sheath during deployment. The plates and frame are made as a separate unit from the nitinol cage.
It may be attached to the cage at either end. This again allows for stability of the plate position after deployment as well as aids pushability during deployment.
= CA 03003341 2018-04-26 The proximal and distal surfaces of the cage may be covered by additional layers of thin p.u.. These layers may be inserted, and may be attached, on an inside surface of the opposite proximal and distal ends of the cage. Hence a total of 5 p.u.
plates aid thrombogenicity: 2 at either end of the cage and 3 internally lined as a separate framed piece.
The stainless steel shanks may be modified to be grasped by clawed-forceps during delivery as is shown in figure 9. The shanks terminate in bulbous grasping heads. In an alternative embodiment, the shoulders of the occulder may be more rounded as shown.
This invention thus provides an aneurysm occluder which can fill or assist to fill the cavity of an aneurysm. It will be readily appreciated by persons skilled in the art that when the aneurysm occluder 1 is constrained in the aneurysm cavity, the housing and insert slows or inhibits flow of blood and thus promotes thrombosis.
It will be appreciated that many variations are possible with the present embodiment according to the invention without departing from the scope of spirit of the invention.
BREDENKAMP ATTORNEYS
AGENTS/ATTORNEYS FOR THE APPLICANT
Claims (10)
1. An aneurysm occluder, comprising a resiliently deformable cage made of a mesh structure in which the mesh structure is cylindrical in cross section and closed off at opposite ends, where the opposite ends are held and closed off with shanks.
2. An occluder as claimed in claim 1 in which the mesh strands are double strands.
3. An occluder as claimed in any one of the preceding claims in which the cage has a frame insert.
4. An occluder as claimed in claim 3 in which the frame insert is a substantially closed rectangular frame, having sheet material attached therein, with the frame bent over itself to form a number of distinct sections.
5. An occluder as claimed in claim 4 in which the frame is resiliently deformable from its bent condition.
6. An occluder as claimed in any one of the preceding claims in which the cage includes sheet inserts or plates at its opposite ends.
7. An occluder as claimed in claim 6 in which the sheets or plates are made of any flat polyurethane or ptfe sheet material.
8. An occluder as claimed in any one of the preceding claims in which each shank terminates, at its outer end, in a bulbous gripping member.
9. An occluder as claimed in claim 8 in which the bulbous gripping members facilitate the grasping thereof by clawed forceps during delivery, in use.
10.A method of manufacturing an aneurism occluder comprising the steps of providing the closed off double strand mesh cage with its shanks and inserting a deformable frame insert therein.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ZA2015/02865 | 2015-10-28 | ||
ZA201502865 | 2015-10-28 | ||
PCT/IB2016/056470 WO2017072692A1 (en) | 2015-10-28 | 2016-10-27 | Aneurysm occluder |
Publications (1)
Publication Number | Publication Date |
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CA3003341A1 true CA3003341A1 (en) | 2017-05-04 |
Family
ID=58629858
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA3003341A Abandoned CA3003341A1 (en) | 2015-10-28 | 2016-10-27 | Aneurysm occluder |
Country Status (6)
Country | Link |
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US (1) | US11103250B2 (en) |
EP (1) | EP3367925B1 (en) |
BR (1) | BR112018008702A2 (en) |
CA (1) | CA3003341A1 (en) |
ES (1) | ES2897755T3 (en) |
WO (1) | WO2017072692A1 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102017130564A1 (en) * | 2017-12-19 | 2019-06-19 | Phenox Gmbh | Implant for aneurysms |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7153323B1 (en) * | 2000-06-30 | 2006-12-26 | Boston Scientific Scimed, Inc. | Aneurysm liner with multi-segment extender |
US20040193246A1 (en) * | 2003-03-25 | 2004-09-30 | Microvention, Inc. | Methods and apparatus for treating aneurysms and other vascular defects |
US8777974B2 (en) * | 2004-03-19 | 2014-07-15 | Aga Medical Corporation | Multi-layer braided structures for occluding vascular defects |
BR112012010758A2 (en) * | 2009-11-05 | 2019-09-24 | Sequent Medical Inc | multilayer filament devices for treatment of vascular defects |
DE102009058132B4 (en) * | 2009-12-12 | 2014-07-24 | Bentley Surgical Gmbh | Cylindrical occluder for sealing hollow cylindrical body vessels |
US11484318B2 (en) * | 2011-01-17 | 2022-11-01 | Artio Medical, Inc. | Expandable body device and method of use |
WO2013005195A1 (en) | 2011-07-07 | 2013-01-10 | Jayandiran Pillai | Aneurysm occluder |
US9713475B2 (en) * | 2014-04-18 | 2017-07-25 | Covidien Lp | Embolic medical devices |
-
2016
- 2016-10-27 US US15/772,371 patent/US11103250B2/en active Active
- 2016-10-27 CA CA3003341A patent/CA3003341A1/en not_active Abandoned
- 2016-10-27 ES ES16859173T patent/ES2897755T3/en active Active
- 2016-10-27 EP EP16859173.3A patent/EP3367925B1/en active Active
- 2016-10-27 WO PCT/IB2016/056470 patent/WO2017072692A1/en active Application Filing
- 2016-10-27 BR BR112018008702A patent/BR112018008702A2/en active Search and Examination
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EP3367925B1 (en) | 2021-08-25 |
US20180317930A1 (en) | 2018-11-08 |
US11103250B2 (en) | 2021-08-31 |
WO2017072692A1 (en) | 2017-05-04 |
EP3367925A1 (en) | 2018-09-05 |
ES2897755T3 (en) | 2022-03-02 |
EP3367925A4 (en) | 2019-07-31 |
BR112018008702A2 (en) | 2018-10-30 |
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